Maybe the FDA should be made to implement guidelines in a reasonable amount of time that do not restrict treatments as they are doing now.
ICMR clears use of cord blood banking, minimally manipulated stem cells to treat debilitating diseases
Tuesday, April 13, 2010 08:00 IST
Nandita Vijay, Bangalore
Indian Council for Medical Research (ICMR) has consented to permit cord blood banking and use of minimally manipulated stem cells to treat debilitating diseases. A separate mechanism for review and monitoring for research and therapy should be sought from the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).
All cord blood banks need to adhere to the protocols and be registered with the DCGI as per the guidelines applicable to the blood banks. Commercial exploitation of stored blood is regulated. Care must be taken in collection, processing and storage of umbilical cord stem cells to avoid transmission of infections.
These decisions came forth at the ICMR's second 'public consultation' on guidelines for stem cell research in Bangalore. The guidelines provide a mechanism to ensure that research with human stem cells is conducted in a responsible and ethically sensitive manner and complies with all regulatory requirements pertaining to biomedical research in general and stem cell research in particular.
Dr Geeta Jotwani asserted that while use of stem cells has proved that control of degenerative diseases and restoration of damage to organs by various injuries, there was a need for the industry to seek permission and if the usage of stem cells came under the permissible category, then permission was immediate.
However, in the case of Minimally Manipulated Stem Cells and Mesenchymal stem cells (MSCs), adult stem cells found in the bone marrow should have an Institutional Ethics Committee (IEC) and seek approvals from Institutional Committee for Stem Cell Research Therapy (ICSCRT) and the National Apex Committee, (NAC) before carrying out treatment.
Minimally Manipulated Stem Cells are manipulated in culture or developed with additional genes in lab conditions. In the case of embryonic stem cells, ICMR has put blanket ban on its use. Currently, these stem cells sources from embryos are in the restricted category. There are medical centres in the country which are surreptitiously using embryonic stems for therapies.
According to the stem cells industry represented by the Society for Regenerative Medicine and Tissue Engineering, Union government needs to speed up its permission process for carrying out stem cell therapies as it is the only way to provide faster access for care to handle the debilitating health conditions.
In order to pursue therapies in regenerative medicine, there must be a definite common ground set between the government, private players and the scientific staff carrying out high end stem cell research. The Government must first of all make the guidelines and implement them within a reasonable time frame especially in the constitution of the National Apex Committee, (NAC). There must be a robust private -public partnership in the stem cell industry so that each sector is properly represented. The Government must encourage private players to seek clinical grants and must expedite the process in granting their applications.
ICMR clears use of cord blood banking, minimally manipulated stem cells to treat debilitating diseases
Tuesday, April 13, 2010 08:00 IST
Nandita Vijay, Bangalore
Indian Council for Medical Research (ICMR) has consented to permit cord blood banking and use of minimally manipulated stem cells to treat debilitating diseases. A separate mechanism for review and monitoring for research and therapy should be sought from the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).
All cord blood banks need to adhere to the protocols and be registered with the DCGI as per the guidelines applicable to the blood banks. Commercial exploitation of stored blood is regulated. Care must be taken in collection, processing and storage of umbilical cord stem cells to avoid transmission of infections.
These decisions came forth at the ICMR's second 'public consultation' on guidelines for stem cell research in Bangalore. The guidelines provide a mechanism to ensure that research with human stem cells is conducted in a responsible and ethically sensitive manner and complies with all regulatory requirements pertaining to biomedical research in general and stem cell research in particular.
Dr Geeta Jotwani asserted that while use of stem cells has proved that control of degenerative diseases and restoration of damage to organs by various injuries, there was a need for the industry to seek permission and if the usage of stem cells came under the permissible category, then permission was immediate.
However, in the case of Minimally Manipulated Stem Cells and Mesenchymal stem cells (MSCs), adult stem cells found in the bone marrow should have an Institutional Ethics Committee (IEC) and seek approvals from Institutional Committee for Stem Cell Research Therapy (ICSCRT) and the National Apex Committee, (NAC) before carrying out treatment.
Minimally Manipulated Stem Cells are manipulated in culture or developed with additional genes in lab conditions. In the case of embryonic stem cells, ICMR has put blanket ban on its use. Currently, these stem cells sources from embryos are in the restricted category. There are medical centres in the country which are surreptitiously using embryonic stems for therapies.
According to the stem cells industry represented by the Society for Regenerative Medicine and Tissue Engineering, Union government needs to speed up its permission process for carrying out stem cell therapies as it is the only way to provide faster access for care to handle the debilitating health conditions.
In order to pursue therapies in regenerative medicine, there must be a definite common ground set between the government, private players and the scientific staff carrying out high end stem cell research. The Government must first of all make the guidelines and implement them within a reasonable time frame especially in the constitution of the National Apex Committee, (NAC). There must be a robust private -public partnership in the stem cell industry so that each sector is properly represented. The Government must encourage private players to seek clinical grants and must expedite the process in granting their applications.